The trachea surgeon and formerly world-renowned stem cell pioneer Paolo Macchiarini, whose human experimenting left most of his trachea-transplant patients dead or in permanent emergency care, certainly did not intend to restrict himself to regenerating airways. He wanted to grow hearts, and he was likely to have been inspired by his former colleagues in Hannover, Germany.
In a particularly revealing interview with a Russian magazine, Macchiarini explained in spring 2014 how an entire organ can be created:
“You cannot grow an entire organ from the cells of an adult human. Besides the cells, you need something else: donor organ or an artificial carcass”.
Thus, for Macchiarini regenerative medicine was reduced to pressing bone marrow cells into the right mould, either a decellurised donor organ consisting only of collagen fibres, or a plastic scaffold. If the form is of trachea, the bone marrow cells will regenerate a trachea. If the form is that of an oesophagus, they will grow an oesophagus. And if they are seeded of a heart-shaped scaffold, they will produce a real beating heart. This of course is one deeply ignorant and unscientific notion, which blatantly disregards the most basic concepts of developmental biology in favour of medical hubris and false promises. Shockingly, politicians, media, university doctors and even stem cell scientists somehow fell for it. Continue reading “Regenerating in Hannover, Part 1: how Macchiarini got ideas”
Image manipulations are unfortunately a rather widespread practice in biomedical literature, where a large part of research data in figures consists of microscopy or gel images. Some of the most commonly detected issues in this regard are image duplications. These can range from possible negligence like duplicated western blot images, to deliberate data fabrication, evidenced by duplications of select image fragments such as gel bands. Sometimes, it is difficult to believe in the accidental nature of duplications: I reported of a case where one single western blot put an appearance whole twelve times in several publications by the Brazilian diabetes researcher Mario Saad and his colleagues. Some of his papers have been retracted by now.
Elisabeth Bik is not only a competent microbiologist at Stanford University and public-outreach-blogger, she is also a human image fabrication detector. Even the most cleverly spliced band duplications are unlikely to be overlooked by Bik, who by now screened over 20,000 papers from 40 different journals for duplications and other image irregularities. For her project, Dutch-born microbiologist teamed up with colleagues and known research integrity activists Arturo Casadevall and Ferric Fang (who previously established misconduct as lead cause of retractions and demanded a reform of the Nobel Prize). The trio presented the results of Bik’s analysis in a bioarxiv-preprint titled “The Prevalence of Inappropriate Image Duplication in Biomedical Research Publications”, where they calculated that
“3.8% of published papers contained problematic figures, with at least half exhibiting features suggestive of deliberate manipulation”.
Continue reading “Image integrity concerns in papers from a Pfizer lab”
The disgraced surgeon Paolo Macchiarini has now been officially sacked from Karolinska Institutet (KI) in Sweden, while also the entire Ethics Council was dismissed by the new KI Vice Chancellor in the process of creating a new supervisory body, with more extended authority.
European Union terminated in 2014 its FP7 funding to Macchiarini and his partners of the Biotrachea Consortium (yet as I show below, the EU’s follow-up programme Horizon2020 has awarded just now almost €7 Mio for a stage II clinical trial with regenerated trachea by the very same Macchiarini partners at UCL) . The original wording of the EU spokesperson in regard to BIotrachea termination referred to “difficulties related to important deliverables” and declared that “at no time did any EU funding for this project involve activities, tests or investigations with human subjects”. Yet the List of Milestones of Biotrachea contained points like:
- MS10 Report on the in vivo immune responses to tissue-engineered airway grafts in men.
- WT14: Outcome of first trial in man tracheal clinical trial
- WT15: Obtaining of clinical trials authorization for tracheal trial
- WT 16: Obtaining of clinical trials authorization for synthetic tracheal trial
After I confronted EU with this and other documents from Biotrachea suggesting an upcoming clinical trial on human patients, the EU spokesperson issued an update to their earlier statement (the entire EU message at the end):
“A chronological sequence of milestones (MS) and work packages (WP) were proposed under the Description of Action. These defined and described all of the technical activities that were to be carried out. The Commission terminated the project before the milestones and work packages referred to in your message were achieved or delivered”.
Continue reading “Macchiarini, Birchall, Seifalian and EU-funded human experimenting”
The Paolo Macchiarini scandal draws wider circles, and unfortunately, it involves more unnecessary patient deaths though questionable tracheal transplants, this time at the University of Gothenburg in Sweden.
In 2011, scientists at the Sahlgrenska University Hospital of Gothenburg applied a method of bioreactor-engineered trachea (similar to that by Macchiarini) to operate on a 76-year old patient, possibly without a medical necessity (he had asthma since decades). The patient died 23 days later “due to cardiac arrest but with a patent, open, and stable tracheal transplant and intact anastomoses”. This is what the paper (Berg et al, Tissue Eng Part A. 2014) claims, which last author is Suchitra Sumitran-Holgersson, professor of transplantation biology at the Sahlgrenska Academy. The University of Gothenburg described Sumitran-Holgersson as “genius”, in an article presenting her rather unconventional method of purifying endothelial stem cells from patients’ blood. That work she did in collaboration with another Sahlgrenska professor and medical director of the Transplant Center, Michael Olausson.
Continue reading “Sumitran-Holgersson: misconduct and regenerative travesty in Sweden”
Sonia Melo, Portuguese cancer researcher and recipient of the prestigious EMBO Installation Grant, now has her publications investigated by EMBO for suspected image manipulations. Her current and former research institutions are apparently actively avoiding any attempts to scrutinise her papers, some due to very heavy financial conflicts of interest. Yet my information suggests that Melo’s former PhD advisor and co-author, Manel Esteller, is being presently investigated by his research centre in Barcelona.
Melo already had to retract a first-author publication from her PhD period with Esteller from the journal Nature Genetics. The retraction notice admits image duplications:
“We have recently become aware of the presence of duplicated images in the Figures 3 and 4 and Supplementary Figures 5 and 6 in our publication Nat. Genet. 41, 365–370, 2009, that were assembled according to the specified author contributions. We therefore retract the publication for the sake of the high standards we expect for research and scientific journals. All the authors have signed this statement”.
Continue reading “Sonia Melo case: PhD advisor Esteller sham-investigated, postdoc PI Kalluri with $ 80Mio COI”
The Heidelberg-based company TICEBA (abbreviated from Tissue & Cell Banking) is not your ordinary run-of-the-mill cell bank. This German company, scientifically advised by the Harvard professor Markus Frank, claims that our skin contains pluripotent stem cells, which are capable of curing all kinds of diseases. This concept is utterly unsupported by scientific literature, and is widely rejected by stem cell scientists. Nevertheless, there is internet evidence that the company’s founder, Christoph Ganss is already treating patients with these cells, in East Asia and even in EU and in Germany. According to certain (sometimes already removed) internet information, patients are being offered autologous “stem cell” injections not only for beauty treatments, but also as cures for type II diabetes, cardiovascular problems, hereditary degenerative eye diseases, and possibly even cancer.
A small price to pay for youth and health
My investigation started with an advertisement in a Lufthansa in-flight magazine, which I was browsing during my return flight from a family visit in Riga in August 2015. The Heidelberg-based company TICEBA advertised to inclined customers on page 41 under the headline “You will age. Your cells won’t” some very exciting service:
“We like a tiny sample of your skin. Separate the stem cells. Store your stem cells in liquid nitrogen. Forever. Then, one day, when old age or illness overtakes you, we re-programme them. Introduce them back into your body. Regenerate you using your younger, stronger, healthier self. It’s not science fiction. Just science”.
Continue reading “Stem cell cures for everything, Made in Germany by TICEBA”
A large body of scientific nanotechnology literature is dedicated to the biomedical aspect of nanoparticle delivery into cells and tissues. The functionalization of the nanoparticle surface is designed to insure their specificity at targeting only a certain type of cells, such as cancers cells. Other technological approaches aim at the cargo design, in order to ensure the targeted release of various biologically active agents: small pharmacological substances, peptides or entire enzymes, or nucleotides such as regulatory small RNAs or even genes. There is however a main limitation to this approach: though cells do readily take up nanoparticles through specific membrane-bound receptor interaction (endocytosis) or randomly (pinocytosis), these nanoparticles hardly ever truly reach the inside of the cell, namely its nucleocytoplasmic space. Solid nanoparticles are namely continuously surrounded by the very same membrane barrier they first interacted with when entering the cell. These outer-cell membrane compartments mature into endosomal and then lysosomal vesicles, where their cargo is subjected to low pH and enzymatic digestion. The nanoparticles, though seemingly inside the cell, remain actually outside. How so? Continue reading “Do nanoparticles deliver? Merck’s Smart Flares and other controversies”